Downie Samantha, Stillie Alison, Moran Matthew, Sudlow Catherine, Simpson A Hamish R W
Orthopaedics and Trauma Department, The University of Edinburgh, Edinburgh, UK.
Department of Clinical Oncology, Western General Hospital, Edinburgh, UK.
Bone Jt Open. 2021 Feb;2(2):79-85. doi: 10.1302/2633-1462.22.BJO-2020-0173.R1.
Surgery is often indicated in patients with metastatic bone disease (MBD) to improve pain and maximize function. Few studies are available which report on clinically meaningful outcomes such as quality of life, function, and pain relief after surgery for MBD. This is the published protocol for the Bone Metastasis Audit - Patient Reported Outcomes (BoMA-PRO) multicentre MBD study. The primary objective is to ascertain patient-reported quality of life at three to 24 months post-surgery for MBD.
This will be a prospective, longitudinal study across six UK orthopaedic centres powered to identify the influence of ten patient variables on quality of life at three months after surgery for MBD. Adult patients managed for bone metastases will be screened by their treating consultant and posted out participant materials. If they opt in to participate, they will receive questionnaire packs at regular intervals from three to 24 months post-surgery and their electronic records will be screened until death or five years from recruitment. The primary outcome is quality of life as measured by the European Organisation for Research and the Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) C30 questionnaire. The protocol has been approved by the Newcastle & North Tyneside 2 Research Ethics Committee (REC ref 19/NE/0303) and the study is funded by the Royal College of Physicians and Surgeons of Glasgow (RCPSG) and the Association for Cancer Surgery (BASO-ACS).
This will be the first powered study internationally to investigate patient-reported outcomes after orthopaedic treatment for bone metastases. We will assess quality of life, function, and pain relief at three to 24 months post-surgery and identify which patient variables are significantly associated with a good outcome after MBD treatment. Cite this article: 2021;2(2):79-85.
对于转移性骨病(MBD)患者,手术治疗通常用于缓解疼痛并最大化功能。很少有研究报告MBD手术后的生活质量、功能和疼痛缓解等具有临床意义的结果。这是骨转移瘤审计——患者报告结局(BoMA-PRO)多中心MBD研究的已发表方案。主要目标是确定MBD患者术后3至24个月的患者报告生活质量。
这将是一项在英国六个骨科中心进行的前瞻性纵向研究,旨在确定10个患者变量对MBD手术后3个月生活质量的影响。因骨转移接受治疗的成年患者将由其主治顾问进行筛查,并邮寄参与材料。如果他们选择参与,将在术后3至24个月定期收到问卷包,其电子记录将被筛查至死亡或入组后五年。主要结局是通过欧洲癌症研究与治疗组织生活质量问卷(EORTC-QLQ)C30问卷测量的生活质量。该方案已获得纽卡斯尔和北泰恩赛德2研究伦理委员会批准(REC编号19/NE/0303),该研究由格拉斯哥皇家内科医师和外科医师学院(RCPSG)以及癌症外科协会(BASO-ACS)资助。
这将是国际上第一项研究骨科治疗骨转移瘤后患者报告结局的有统计学效力的研究。我们将评估术后3至24个月的生活质量、功能和疼痛缓解情况,并确定哪些患者变量与MBD治疗后的良好结局显著相关。引用本文:2021;2(2):79-85。